NeuroOne Medical Technologies has announced that it successfully completed initial, bench-top, long-term stimulation testing on a novel design of its thin-film electrode technology. The tests measured the electrodes’ ability to deliver the number of electrical stimulation pulses required to meet approximately five years of use via an active accelerated ageing model, a NeuroOne press release states.
The release adds that the results demonstrated the potential to provide chronic stimulation at typical stimulation parameters currently used to treat patients suffering with chronic back pain due to multiple failed back surgeries.
The tests were conducted by recording the number of pulses of stimulation each pair of electrode contacts could deliver before identifying degradation. For a patient with chronic back pain receiving 16 hours of stimulation per day, the testing duration and intensity translates to more than five years of operation, or four-to-five years if operating 24 hours per day, according to NeuroOne.
Camilo Diaz-Botia, director of Electrode Development for NeuroOne, said: “We conducted active accelerated longevity stimulation tests in saline solution, which is known to represent harsher conditions than saline solutions with added proteins. After several months of accelerated testing, we observed that most electrode contacts preserve the ability to deliver stimulation pulses at levels that would benefit most patients. We also observed that the electrode material remained electrochemically stable. Lastly, in agreement with our results on long-term recording, we again observed that the thin film insulation performed well during testing.”
NeuroOne also previously announced successful passive accelerated testing on electrodes that successfully demonstrated the ability to record electrical activity for a minimum of five years.
Dave Rosa, CEO of NeuroOne, added: “Over the past few years, we have been working to develop the technology for long-term use given the large market opportunity for chronic stimulation technology. The results of both the long-term recording and stimulation testing demonstrate we are getting closer to achieving that goal. If we are successful in the ongoing development and subsequent submission to the FDA [Food and Drug Administration], this would enable us to pursue expansion into therapeutic areas such as long-term stimulation for epilepsy, Parkinson’s disease, chronic back pain due to failed back surgeries and other related neurological disorders.
“It may also present opportunities for licensing the technology to strategic partners for applications that are outside of our areas of focus. Our initial area of interest is expected to be spinal cord stimulation for chronic back pain, given the size of the market and the competitive differentiator we can bring to this market with our unique thin-film, low-profile electrode platform.”
As previously reported, the company is advancing a pipeline of therapeutic electrode technologies for brain tissue ablation, chronic stimulation in deep brain stimulation, and spinal cord stimulation for chronic back pain as well. NeuroOne believes these therapeutic electrode technologies are targeted to addressable markets worth over US$10 billion, as per the release.